EU Regulation & US FDA Conformance Declaration

Transcription

1 EU Regulation & US FDA Conformance Declaration REF. NO. FIL FFU/F-AUU/2016 Date: December 19, 2016 We hereby confirm that our products: FLEXPET & FLEXMETPROTECT (F-ATT, F-ATU, F- AUU-F-AUT, F-CLR-A1 F-ESB, F-ESC, F-PAB, F-XLR-A1, FAUU-M, F-AUT-M, F-CLR-A1-M, F- PAB-M, F-XLR-A1-M F-CLR-A1-PZ, F-XLR-A1-PZ) manufactured in Elizabethtown, Kentucky, are manufactured from Polyethylene terephthalate polymers (PET) as identified with Code 1 in the list of Annexure 1 of Directive 97/129/EC; in accordance with the procedure laid down in Article 1 of Directive 94/62/EC. Food and Drug Administration Food Packaging Regulations The above mentioned FLEXPET & FLEXMETPROTECT film grades comply with FDA Regulation 21 CFR for films made of Polyethylene terephthalate polymers and conditions of use (f), (g), and (h) for direct food contact. These materials are suitable for food grade applications including at temperatures of 250 F and above during cooking. The above mentioned FLEXPET & FLEXMETPROTECT film grades are suitable for food grade applications including alcoholic beverages that do not exceed 50% alcohol by volume. The films are used in accordance with the Good Manufacturing Practice (GMP) regulations, defined in 21 CFR The films are produced in a way to assure that the packaging will neither endanger human health nor bring about unacceptable changes in the composition of food or cause organoleptic changes thereof. European Union Food Contact Packaging Regulations The above mentioned FLEXPET & FLEXMETPROTECT film grades comply with European EU Directive 2011/65/EU, RoHS, 76/769EEC, 94/62/EEC, and 2003/11/EC. The above mentioned FLEXPET & FLEXMETPROTECT film grades are manufactured with monomers and starting substances listed on the Union List in Commission Regulation (EU) 10/2011 amended until (EU) 2016/1416. These regulations are related to plastic materials and articles intended to come in contact with foodstuffs. The above mentioned FLEXPET & FLEXMETPROTECT grades comply with article 17, Regulation (EC) 1935/2004, traceability requirement. Flex Films (USA) Inc. uses an 11-digit roll number on the roll labels supplied with our film rolls. To trace back any of these FLEXPET & FLEXMETPROTECT grades of films, the 11-digit roll number should be noted. The above mentioned FLEXPET & FLEXMETPROTECT grades comply with the requirements of Directive 2004/1935/EC as amended to Commission Regulation (EC) 450/2009. Based on results obtained from specific migration testing and declarations submitted to us by our suppliers, the above mentioned FLEXPET & FLEXMETPROTECT grades do not contain epoxy derivatives as under and therefore in compliance with regulation 1895/2005/EC amended to Directives 2002/16/EC followed by 2004/13/EC. (a) Bisphenol A Di-Glycidyl Ether (BADGE) (b) 2,3-dihydroxypropyl ether (BADGE.H20) Primer Coated Films EU/FDA Conformance Declaration pg. 1

2 (c) 3-chloro-2-hydroxypropyl glycidyl (BADGE.HCL) (d) (3-chloro-2-dydroxypropyl) (2,3-dihydroxypropyl) ether (BADGE.H20.HCL) (e) 3-chloro-2-hydroxyphenyl ether (BADGE.2HCL) (f) Bis (4-hydroxyphenyl) methane (BFDGE) (g) Novolac glycidyl ethers (NOGE) Health Canada Food Packaging Materials The above mentioned FLEXPET & FLEXMETPROTECT film grades have been submitted to Canada Food Inspection Agency to obtain a letter stating our product is suitable to be used in contact with all food types in general food packaging applications. We do not believe there will be any objections to our product for their intended use. The above mentioned FLEXPET & FLEXMETPROTECT film grades are pending a Letter of Non- Objection, Reference: KS REACH The above mentioned FLEXPET & FLEXMETPROTECT film grades comply with European Parliamentary Regulation (EC) No. 1907/2006, the regulation, evaluation and authorization of chemicals (REACH). To the best of our current knowledge and according to supplier s declarations, we hereby declare that the above mentioned FLEXPET & FLEXMETPROTECT film grades do not contain any substances identified as SVHC s at levels greater than 0.1% (w/w). California s Safe Drinking water and Toxic Enforcement Act The above mentioned FLEXPET & FLEXMETPROTECT grades are manufactured with chemicals listed under the California Proposition 65, The Safe Drinking Water and Toxic Enforcement Act of 1986 (last updated on October 21, 2016). However, based on internal review and outside expert review, our film product are not subject to reporting under the current regulation. Toxic Substance Control Act (TSCA) known chemicals subject to TSCA. Heavy Metals & Conflict Minerals known heavy metals subject to Coalition of Northeastern Governors legislation, such as lead, cadmium, mercury, and hexavalent chromium. We certify that the composition for the above mentioned FLEXPET & FLEXMETPROTECT grades do not knowingly contain PBBs or PBDEs (and their compounds), including decabde. We certify that the composition for the above mentioned FLEXPET & FLEXMETPROTECT grades do not knowingly contain such heavy metals and comply with CONEG. known conflict minerals subject to the Dodd-Frank Act, of the Securities Exchange Act of 1934, such as gold, wolframite, cassiterite, columbite-tantalite (coltan) or their derivate OR any other mineral or its derivatives determined by the Secretary of State to be financing conflict in the DRC (Democratic Republic of the Congo) or an adjoining country in the manufacturing of their products. Primer Coated Films EU/FDA Conformance Declaration pg. 2

3 any source of tin {Dibutyltin (DBT), Tributyltin (TBT), Monobutyltin (MBT), Alkyltin, or other organ tin compounds. Allergens The above mentioned FLEXPET & FLEXMETPROTECT film grades are not knowingly formulated with known allergens, such as: wheat (and its by-products), crustaceans or shellfish, eggs (and its byproducts), fish, milk (and its by-products), peanuts (and it s by-products), soybeans (and its by-products), seeds, tree nuts, gluten (and its by-products), mustard (and its by products), celery (and its by products), lupine (and its by-products), sulphites (and its by-products) food colorings, aspartame, or MSG. Additives The above mentioned FLEXPET & FLEXMETPROTECT film grades comply with EU 10/2011, amended until (EU) 2016/1416, and the German Federal Institute for Risk Assessment (BFR), previously known as BgVV & BGA, plastic directive for additives safe for use. We certify that the composition for the above mentioned FLEXPET & FLEXMETPROTECT grades do not substantially migrate or transfer their constituents into food in quantities having a technical effect on final food. lipophilic substances (10/2011/EC). dual-use additives (Article 5, Directive 2011/10/EU). genetically modified organisms (GMO). cellulose. azocolorants. Tris (nonylphenol) phosphite (TNPP) additives. perchlorate or perfluorocarboxylates. Animal Derivatives substances derived from animals. Flex Films (USA) Inc. received a Kosher certification on November 10, 2016; Reference ID: FTX-CMPQ. The above mentioned FLEXPET & FLEXMETPROTECT film grades comply FDA regulations 21 CFR 189 and 700, USDA regulation 9 CFR 94.18, and/or international regulations European Commission Directives governing the potential risk of bovine spongiform encephalopathy (BSE) & transmittable spongiform (TSE) in human food; including dietary supplements, and cosmetics. Primer Coated Films EU/FDA Conformance Declaration pg. 3

4 Phthalates substances or constituents of phthalates. The above mentioned FLEXPET & FLEXMETPROTECT film grades comply with Directive 2005/84/EC, amending Directive 76/769/EEC. Based upon the results obtained from specific migration testing and declarations of raw material supplier, we confirm that phthalates mentioned below are not added at any stage of manufacture by us or in additive by our suppliers. bis (2-ethylhexyl) phthalate (DEHP) dibutyl phthalate (DBP) benzyl butyl phthalate (BBP) diisononyl phthalate (DINP) diisodecyl phthalate (DIDP) di-n-octyl phthalate (DNOP) di-n-hexyl phthalate (DNHP) diethyl phthalate (DEP) di(methoxyethyle) phthalate (DMEP) dipentyl phthalate (DPEP) Latex latex. Ozone ozone depleting agents, as defined by Directive 2000/2037/EC. Asbestos raw materials or chemicals agents that may contain asbestos; nor is there a potential of risk during the manufacturing process, as defined by Directive 2003/18/EC. Based upon our knowledge of the process and product, we do not expect asbestos to be present; and therefore, do not test our product for these substances. Bisphenol-A (BPA) BPA. Hazardous Chemicals The above mentioned FLEXPET & FLEXMETPROTECT grades are not classified as hazardous chemicals, as defined by 67/548/EEC and 1999/45/EC; and therefore, are not subject to hazardous chemical labelling. Primer Coated Films EU/FDA Conformance Declaration pg. 4

5 The above mentioned FLEXPET & FLEXMETPROTECT grades are not classified as hazardous to water, as defined by German regulation, no WGK. substances forbidden or restricted by chemical prohibition regulations 76/69/EC and its amendments 2006/122/EC. The above mentioned FLEXPET & FLEXMETPROTECT grades do not form materials that require monitoring or special supervision as laid down in the Act for Promoting Closed Substance Cycle Waste management and Ensuring Environmentally Compatible Waste Disposal and in the Directives 91/689/EEC and 91/156/EEC, i.e. it is not hazardous waste. Recycle Material The above mentioned FLEXPET & FLEXMETPROTECT grades comply with LFGB 30 and 31, Book of Legislations for Food Stuff, Daily Needs and Animal Feed (edition as of September 1, 2005) and Regulation for the Use of Daily Needs (from April 10, 1992, modified on December 21, 2000), Commission Regulation (EU) 2015/1906 of October 22, 2016, on recycled material intended to come into contact with food. The above mentioned FLEXPET & FLEXMETPROTECT grades comply with Regulation (EC) 2023/2006, which defines the use of waste material used for manufacturing: the offcuts and scraps from the manufacturing of plastic intended for the use as food contact material and that has not been in contact with food, or otherwise contaminated, that has been re-melted to be re-used into new product, or to be sold to a third party as part of a quality control system, in compliance with rules for good manufacturing practice. recycled material produced by chemical de-polymerization. Migration Limits Plastic materials are not fully inert. There are substances which can transfer, or migrate, from the plastic packaging into the food and vice versa. The migration of substances are regulated by Directive (EU) 10/2011 and its amendment, (EU) 2016/1416, with two different migration limits: Overall Migration Limits: Directive (EU) 10/2011, 2013/46/EC & 2006/125/EC limits the permissible overall migration limits i.e. the total quantity of substances released be the sample to 60 mg/kg, or 10 mg/dm², under the test conditions set out in Annex III; in accordance with the rules set out in chapter 3, section 3.1 of Annex V. The above mentioned FLEXPET & FLEXMETPROTECT grades meet the overall migration limits. --Test results as reported by SGS on October 10, Full report available upon request. Primer Coated Films EU/FDA Conformance Declaration pg. 5

6 Specific Migration Limits: Directive (EU) 10/2011, amended until (EU) 2016/1416, stipulates specific migration limits (mg/kg food) for certain substances. The above mentioned FLEXPET & FLEXMETPROTECT grades meet the specific migration limits, under the test conditions set out in Annex III; in accordance with the rules set out in chapter 2, section 2.1 of Annex V. The specific migration values given in mg/kg food are converted to mg/dm³ of film surface by multiplying with the standard conversion factor 6; because by definition 1 kg food are enclosed by 6dm² of film. The following limitations apply under Directive (EU) 10/2011 as amended or as differently specified: PM Ref. CAS No. Substances Limitations Ethylene glycol SML (T) = 30 mg/kg Formaldehyde SML (T)(*) = 15 mg/kg Melamine SML (*) = 2.5 mg/kg Meth acrylamide SML= ND (DL=0.01 mg/kg) Terephthalic acid SML (T) = 7.5 mg/kg Sodium bisulphite SML(T)(*)= 10 mg/kg (expressed as SO2) Acrylic acid & its esters SML(T)(*)= 6 mg/kg Meth acrylic acid & its esters SML(T)(*)= 6 mg/kg Acids SML(T)(*)= 2 mg/kg under resolution AP(92) Peroxides SML(T)(*)= 0.05 mg/kg (as O) when extracted in distilled water under AP(92) Thiols SML(T)(*)= 1 mg/kg as S in organic moiety under AP(92)2 With regard to the results obtained from the testing of these films under the above mentioned test conditions for specific migration limits, as well as overall migration. We hereby declare that above mentioned grades comply with the Regulation (EU) 10/2011 Annex, Table I amended until (EU) 2016/1416. Results that we have obtained from testing of these films regarding Annex II are shown below. IN regards to Polyaromatic Amines; PAA s are not intentionally or unintentionally added to our product and therefore testing has not been conducted. Primer Coated Films EU/FDA Conformance Declaration pg. 6

7 -- Test results as reported by SGS on August 4, Full report available upon request. Specifications on use: Types of food intended to come into contact with the material: All food types, except as noted. Types of food not intended to come into direct contact with the material: alcoholic food >50% concentration. Ratio of the area of the food contact material to the volume used to determine the compliance: (1.0 ml/cm²). Flex Films (USA) Inc. complies with the above mentioned regulations. We, as a film manufacturer, have fulfilled our responsibility of care regarding the conformance of the above FLEXPET & FLEXMETPROTECT grades supplied with the legislation governing food contact applications. The information applies only to the above mentioned FLEXPET & FLEXMETPROTECT grades and does not apply to use in any process or in combination with any other material. This information is provided at request. Flex Films (USA) Inc. recommends that you make your own determination of the suitability of this film to your particular application. The conditions of use are outside the control of Flex Films (USA) Inc. We at Flex Films (USA) Inc. make no warranties, expressed or implied, and assume no liability in connection with any use of this information. The user may share this information with their customers and regulatory bodies, as needed for assessing compliance or measuring migration. The user and their customers may not share the information or pass information to others; in particular to our competitors. We will inform you of any changes in the composition of our above FLEXPET & FLEXMETPROTECT grades that are relevant to food legislation or changes in legislation, which affects the regulatory status. We moreover recommend that you verify on a regular basis, with our marketing representative, the latest contact status of our product. Primer Coated Films EU/FDA Conformance Declaration pg. 7